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Идёт набор NCT07425769

Adapting RDAD for DS

Без фазы С лечением Down Syndrome (DS) Alzheimer's Disease (AD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Remote Exercise Sessions, Caregiver Education Sessions.
Кому может быть актуально
Состояния в реестре: Down Syndrome (DS), Alzheimer's Disease (AD). Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test

Обзор

The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.

Подробное описание

In Adapting RDAD for DS Phase 3 (CareFit-DS/AD), we will conduct a 12-week, single arm pilot trial intervention in 20 adults with DS/caregiver dyads. This intervention includes remote-delivered functional exercise classes for adults with DS and their caregivers, and remote delivered dementia caregiving training sessions for the caregivers. Participants with DS will complete 12 weeks of group exercise sessions (three \~30-minute sessions per week, caregiver optional) over video call, and caregivers will also receive a weekly \~40-minute group video call session of a dementia caregiver training/support group.

For participants within 50 miles of the study site, staff will travel to participant homes at baseline and following 12 weeks to perform assessments of physical function and to set up the Actigraph accelerometers. Saliva collection kits for caregivers will be mailed ahead of time and picked up at the home visit. Additionally, at baseline staff will deliver equipment for intervention delivery

For participants greater than 50 miles of the study site, staff will mail study equipment, including the Actigraph accelerometer, and schedule a video orientation meeting to assist with equipment setup. Physical function and caregiver saliva collection will not be collected for these participants.

Twelve unique pre-recorded exercise class sessions (endurance, strength, balance, and flexibility) will be performed 3 times each throughout the study (36 sessions total). The exercise session content and frequency are designed to improve functional fitness for daily activities and will challenge participants at a light and/or moderate intensity level. During the sessions, all participants will join a video call and follow along with a pre-recorded exercise video in a group format. A staff member trained in working with the population will be on the call to provide encouragement and feedback, while monitoring for participant safety. Caregivers may attend and participate in the exercise sessions, but will neither be encouraged or discouraged from doing so.

Caregivers will be asked to attend weekly group behavioral management training sessions via video call immediately following one of the 3 exercise sessions. These meetings will consist of information and resources for caregiving for a person with DS who has been diagnosed with dementia. The group will be moderated by a staff member trained in working with the population and will include presented information as well as group discussion time. Topics include the Overview of Alzheimer's Disease in Down Syndrome; Behavior Management Strategies, Changing Expectations, etc.

Вмешательства

  • Поведенческое Remote Exercise Sessions
    Participants will take part in thrice weekly exercise sessions using pre-recorded videos designed for older adults with Down syndrome. Participants will join video call and follow along with the video. A staff member familiar with the population will be on the call to provide modifications, encouragement and ensure participant safety.
  • Поведенческое Caregiver Education Sessions
    Caregivers will join a once-weekly education session held via video call and led by a trained staff member. Education content will include how to support and manage challenging behaviors of older adults with Down syndrome who may be experiencing Alzheimer's disease-related symptoms.

Первичные конечные точки

  • Feasibility: Participant Recruitment [Срок оценки: Baseline]
  • Feasibility: Recruitment Rate [Срок оценки: Baseline]
  • Feasibility: Participant retention [Срок оценки: Baseline to Week 12]
  • Feasibility: Session Attendance [Срок оценки: Across 12 week intervention]
  • Feasibility: Participant Safety [Срок оценки: Across 12 week intervention]
Вторичные конечные точки (12)
  • Participant Sedentary Time [Срок оценки: Baseline and Week 12]
  • Participant Physical Activity [Срок оценки: Baseline and Week 12]
  • Participant Five Times Sit to Stand [Срок оценки: Baseline and Week 12]
  • Participant Timed Up and Go [Срок оценки: Baseline and Week 12]
  • Participant 2 Minute Step Test [Срок оценки: Baseline and Week 12]
  • Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4) [Срок оценки: Baseline and Week 12]
  • Participant Hand Grip Strength [Срок оценки: Baseline and Week 12]
  • Participant Basic and Instrumental Activities of Daily Living [Срок оценки: Baseline and Week 12]
  • Participant Behavioral Symptom-Related Severity [Срок оценки: Baseline and Week 12]
  • Participant Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c [Срок оценки: Baseline and week 12]
  • Caregiver Sedentary Time [Срок оценки: Baseline and Week 12]
  • Caregiver Physical Activity [Срок оценки: Baseline and Week 12]

Критерии участия

Inclusion Criteria - Adults with Down syndrome:

  • Age >35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \~31 in adults with DS.
  • Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.
  • Living at home or in a supported living environment with a parent/caregiver who agrees to serve as a study partner.
  • Self-reported ability to participate in physical activity.

Exclusion Criteria - Adults with Down syndrome:

  • Unable to participate in moderate-to-vigorous physical activity.
  • Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.

Inclusion Criteria - Caregivers

  • Age ≥18 yrs.
  • Reports being a primary caregiver of an adult with DS.
  • English speaking.
  • Self-reported ability to participate in physical activity.

Exclusion Criteria - Caregivers

  • Unable to participate in moderate PA, i.e., brisk walking.
  • Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT07425769 · STUDY00162196 · KL2TR002367

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗